Second Quarter Net Sales Grew to
–Announced FDA Approval of New Dosing Formulation and Strength ofNUPLAZID® (Pimavanserin)
–Expanded ACADIA’s Pipeline in Central Nervous System Disorders withExclusive License Agreement for the
“In the second quarter, NUPLAZID delivered 17% revenue growth and 3%sequential volume growth. We remain focused on our initiatives toprovide physicians, patients and caregivers access to NUPLAZID’s robustsafety and efficacy data and to improve the lives of patients livingwith Parkinson’s disease psychosis,” said
Recent Highlights
- Announced an exclusive license agreement with
Neuren Pharmaceuticals (ASX: NEU) for the North American development and commercialization oftrofinetide for all indications, including Rett syndrome, a rareneurodevelopmental CNS disorder. Trofinetide is a novel syntheticanalog of the amino-terminal tripeptide of IGF-1 designed to treat thecore symptoms of Rett syndrome by reducing neuroinflammation andsupporting synaptic function. - Announced
FDA approval of a new 34 mg single capsule formulation ofNUPLAZID to help in the treatment of patients living withhallucinations and delusions associated with Parkinson’s diseasepsychosis. - Completed enrollment in the Phase 2 CLARITY study assessingpimavanserin as a potential adjunctive treatment for major depressivedisorder.
- Appointed
Austin D. Kim as Executive Vice President, General Counseland Secretary.
Financial Results
Revenue
Net sales of NUPLAZID were
Research and Development
Research and development expensesfor the three months ended
Selling, General and Administrative
Selling, general andadministrative expenses for the three months ended
Net Loss
For the three months ended
Cash and Investments
At June 30, 2018, ACADIA’s cash, cashequivalents and investment securities totaled
Financial Guidance
ACADIA is lowering its 2018 NUPLAZID net sales guidance to be between
For the third quarter of 2018, ACADIA expects NUPLAZID net sales to bebetween
ACADIA is lowering its guidance for its year end 2018 cash, cashequivalents and investment securities on its balance sheet to be between
Conference Call and Webcast Information
ACADIA managementwill review its first quarter financial results and operations viaconference call and webcast today at
About NUPLAZID® (pimavanserin)
NUPLAZIDis the first FDA-approved treatment for hallucinations and delusionsassociated with Parkinson’s disease psychosis. NUPLAZID is anon-dopaminergic, selective serotonin inverse agonist preferentiallytargeting 5-HT2A receptors that are thought to play animportant role in Parkinson’s disease psychosis. NUPLAZID is an oralmedicine taken once a day with a recommended dose of 34 mg. ACADIAdiscovered and developed this new chemical entity and holds worldwiderights to develop and commercialize NUPLAZID.
About
ACADIA is a biopharmaceuticalcompany focused on the development and commercialization of innovativemedicines to address unmet medical needs in central nervous systemdisorders. ACADIA has developed and is commercializing the first andonly medicine approved for the treatment of hallucinations and delusionsassociated with Parkinson’s disease psychosis. In addition, ACADIA hasongoing clinical development efforts in additional areas withsignificant unmet need including dementia-related psychosis,schizophrenia inadequate response, schizophrenia-negative symptoms,major depressive disorder and Rett syndrome. This press release andfurther information about ACADIA can be found at: www.acadia-pharm.com.
Forward-Looking Statements
Statements in this press releasethat are not strictly historical in nature are forward-lookingstatements. These statements include, but are not limited to, statementsrelated to: the potential opportunity for future growth in sales ofNUPLAZID, including through sales of new dosages and forms; the timingof results from our study in major depressive disorder and the timing ofother ongoing clinical studies; the development and commercialization oftrofinetide; and guidance for third quarter NUPLAZID net sales andcertain expense line items. These statements are only predictions basedon current information and expectations and involve a number of risksand uncertainties. Actual events or results may differ materially fromthose projected in any of such statements due to various factors,including the uncertainty of future commercial sales and related itemsthat would impact net sales during 2018, the risks and uncertaintiesinherent in drug discovery, development, approval and commercialization,and the fact that past results of clinical trials may not be indicativeof future trial results. For a discussion of these and other factors,please refer to ACADIA’s annual report on Form 10-K for the year ended
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) | ||||||||||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||||||||||
| Revenues | ||||||||||||||||||||||||
| Product sales, net | $ | 57,063 | $ | 30,475 | $ | 105,931 | $ | 45,761 | ||||||||||||||||
| Total revenues | 57,063 | 30,475 | 105,931 | 45,761 | ||||||||||||||||||||
| Operating expenses | ||||||||||||||||||||||||
| Cost of product sales, license fees and royalties | 5,078 | 3,206 | 8,563 | 6,144 | ||||||||||||||||||||
| Research and development | 46,592 | 34,180 | 85,868 | 69,589 | ||||||||||||||||||||
| Selling, general and administrative | 69,472 | 61,125 | 130,398 | 126,785 | ||||||||||||||||||||
| Total operating expenses | 121,142 | 98,511 | 224,829 | 202,518 | ||||||||||||||||||||
| Loss from operations | (64,079 | ) | (68,036 | ) | (118,898 | ) | (156,757 | ) | ||||||||||||||||
| Interest income, net | 1,279 | 993 | 2,449 | 1,956 | ||||||||||||||||||||
| Other expense | (247 | ) | — | (247 | ) | — | ||||||||||||||||||
| Loss before income taxes | (63,047 | ) | (67,043 | ) | (116,696 | ) | (154,801 | ) | ||||||||||||||||
| Income tax expense | 219 | 398 | 866 | 483 | ||||||||||||||||||||
| Net loss | $ | (63,266 | ) | $ | (67,441 | ) | $ | (117,562 | ) | $ | (155,284 | ) | ||||||||||||
| Net loss per common share, basic and diluted | $ | (0.51 | ) | $ | (0.55 | ) | $ | (0.94 | ) | $ | (1.27 | ) | ||||||||||||
| Weighted average common shares outstanding, basic and diluted | 124,910 | 122,122 | 124,819 | 121,888 | ||||||||||||||||||||
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) | |||||||||||||||||
| June 30, 2018 | December 31, 2017 | ||||||||||||||||
| (unaudited) | |||||||||||||||||
| Assets | |||||||||||||||||
| Cash, cash equivalents and investment securities | $ | 256,855 | $ | 341,342 | |||||||||||||
| Accounts receivable, net | 25,696 | 17,343 | |||||||||||||||
| Interest and other receivables | 986 | 1,087 | |||||||||||||||
| Inventory | 4,737 | 5,248 | |||||||||||||||
| Prepaid expenses | 12,822 | 8,457 | |||||||||||||||
| Total current assets | 301,096 | 373,477 | |||||||||||||||
| Property and equipment, net | 2,760 | 2,662 | |||||||||||||||
| Intangible assets, net | 4,800 | 5,538 | |||||||||||||||
| Restricted cash | 3,111 | 2,475 | |||||||||||||||
| Other assets | 3,193 | 354 | |||||||||||||||
| Total assets | $ | 314,960 | $ | 384,506 | |||||||||||||
| Liabilities and stockholders’ equity | |||||||||||||||||
| Accounts payable | $ | 3,333 | $ | 8,786 | |||||||||||||
| Accrued liabilities | 45,881 | 40,244 | |||||||||||||||
| Total current liabilities | 49,214 | 49,030 | |||||||||||||||
| Long-term liabilities | 1,026 | 191 | |||||||||||||||
| Total liabilities | 50,240 | 49,221 | |||||||||||||||
| Total stockholders’ equity | 264,720 | 335,285 | |||||||||||||||
| Total liabilities and stockholders’ equity | $ | 314,960 | $ | 384,506 | |||||||||||||
Important Safety Information and Indication forNUPLAZID (pimavanserin)
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITHDEMENTIA-RELATED PSYCHOSIS
Elderly patients withdementia-related psychosis treated with antipsychotic drugs are at anincreased risk of death. NUPLAZID is not approved for the treatment ofpatients with dementia-related psychosis unrelated to the hallucinationsand delusions associated with Parkinson’s disease psychosis.
NUPLAZID is an atypical antipsychotic indicated for the treatment ofhallucinations and delusions associated with Parkinson’s diseasepsychosis.
Contraindication: NUPLAZID is contraindicated in patients with a historyof a hypersensitivity reaction to pimavanserin or any of its components.Rash, urticaria, and reactions consistent with angioedema (e.g., tongueswelling, circumoral edema, throat tightness, and dyspnea) have beenreported.
QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use ofNUPLAZID should be avoided in patients with known QT prolongation or incombination with other drugs known to prolong QT interval includingClass 1A antiarrhythmics or Class 3 antiarrhythmics, certainantipsychotic medications, and certain antibiotics. NUPLAZID should alsobe avoided in patients with a history of cardiac arrhythmias, as well asother circumstances that may increase the risk of the occurrence oftorsade de pointes and/or sudden death, including symptomaticbradycardia, hypokalemia or hypomagnesemia, and presence of congenitalprolongation of the QT interval.
Adverse Reactions: The most common adverse reactions (≥2% for NUPLAZIDand greater than placebo) were peripheral edema (7% vs 2%), nausea (7%vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%),constipation (4% vs 3%), and gait disturbance (2% vs <1%).
Drug Interactions: Coadministration with strong CYP3A4 inhibitors (e.g.,ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mgtaken orally as one tablet once daily. Coadministration with strongCYP3A4 inducers may reduce NUPLAZID exposure. Monitor patients forreduced efficacy and an increase in NUPLAZID dosage may be needed.
Pediatric Use: Safety and efficacy have not been established inpediatric patients.
Dosage and Administration: Recommended dose: 34 mg taken orally oncedaily, without titration.
NUPLAZID is available as 34 mg capsules, 17 mg tablets and 10 mg tablets.
For additional Important Safety Information, including Boxed WARNING,please see the full Prescribing Information for NUPLAZID at https://www.nuplazid.com/pdf/NUPLAZID_Prescribing_Information.pdf.
Source:
Investor Contact:
ACADIA Pharmaceuticals Inc.
ElenaRidloff, CFA
(858) 558-2871
ir@acadia-pharm.com
or
MediaContact:
Taft Communications
Bob Laverty
(609)558-5570
bob@taftcommunications.com